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LigoCyte Pharmaceuticals Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
Date:9/8/2009

BOZEMAN, Mont., Sept 8 /PRNewswire/ -- LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo. Clinical studies to date have shown the vaccine to be immunogenic and generally well tolerated in human subjects.

"Norovirus infections are now being recognized as a widespread problem that can have very serious consequences," said Donald P. Beeman, CEO of LigoCyte. "The worldwide impact of this highly contagious virus has been increasingly appreciated with the continued closures of hospital wards, long-term care facilities, and schools."

Norovirus infection, well known as the "stomach flu," is the most common cause of acute gastroenteritis, afflicting nearly 23 million Americans annually. Norovirus infection is characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea, and occasionally fever. Severe clinical outcomes are associated with at-risk populations, where complications caused by infection can disrupt primary treatment regimens and even lead to death. Noroviruses are highly infective and easily transmitted. Epidemic outbreaks occur in community environments, particularly hospitals, hotels, schools, and nursing homes, resulting in significant risk to immunocompromised individuals and mounting socioeconomic cost to families, the health care system and businesses. Military units are also affected, as outbreaks represent a significant readiness issue for naval vessels and land-based installations.

LigoCyte's norovirus vaccine is a needle-
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SOURCE LigoCyte Pharmaceuticals, Inc.
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